MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number	010001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the device broke during the surgery inside the patient's anatomy.The broken pieces were removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
One(b)(4) straight probe returned.The complaint stated: ¿the device broke during the surgery inside the patient's anatomy.The broken pieces were removed from the patient.¿ this is a reusable probe.The entire tip incremental marking section has been broken off.The broken portion approximately 1.25¿ piece was not returned.The condition is consistent with the instrument being used for leverage or becoming fatigued.With any surgical instrument, it should be ensured that excessive force is not placed upon the product.No root cause related to the manufacture of this device was confirmed.No further investigation is warranted at this time.

• Brand Name: PROBE STRAIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8237250
• Report Number: 1219602-2019-00057
• Device Sequence Number: 1557668
• Product Code: NBH
• UDI-Device Identifier: 03596010021533
• UDI-Public: 03596010021533
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 010001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1